System and method for integrating the internal and external quality control programs of a laboratory

ABSTRACT

A system and method that enables a laboratory to integrate its internal and external quality control programs to thereby control the quality of its laboratory testing services. The system has a storage device and a processor operable to maintain in the storage device a database identifying a plurality of laboratory tests and the corresponding internal laboratory statistical data, group statistical summary data and control rules. The processor is also operable to calculate a control range for a specified laboratory test by applying the group statistical summary data (and, in some cases, the internal laboratory statistical data) to the control rule corresponding to the specified laboratory test. Preferably, the processor is also operable to receive a test result from a laboratory instrument, and determine whether the test result falls within the calculated control range for the specified laboratory test. Various exemplary embodiments of the system and associated method are provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. patent application Ser. No.10/428,584, filed on May 2, 2003, which is hereby incorporated herein byreference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable.

FIELD OF THE INVENTION

The present invention relates generally to laboratory testing servicesand, more particularly, to a system and method that enables a laboratoryto integrate its internal and external quality control programs tothereby control the quality of its laboratory testing services.

BACKGROUND OF THE INVENTION

There are many techniques used to test the functionality of laboratoryinstruments for the purpose of controlling the quality of laboratorytesting services. One common practice is to test a stable specimenhaving predetermined characteristics (also known as a quality controlspecimen) and verify that the test result falls within a predicted rangeof acceptable values (also known as a control range) for a specifiedlaboratory test. Typically, the control range is either derived from themanufacturer of the quality control material, arrived at by internallaboratory testing (i.e., by applying internal laboratory statisticaldata to a control rule), or a combination of the two. If the test resultfalls within the control range, the laboratory instrument is deemed tobe functioning properly and is thus suitable for testing actual patientspecimens. On the other hand, the laboratory instrument is deemed to bemalfunctioning if the test result does not fall within the controlrange. This practice is referred to as the internal quality controlprogram of the laboratory.

In addition to implementing an internal quality control program, manylaboratories participate in external quality control programs (alsoknown as peer-group quality control programs). A typical peer-groupquality control program consists of a collection of participatinglaboratories that test quality control specimens from the same sourceand submit the test results to a central agency. The central agency thencomputes group statistical summaries of the submitted test results andsends reports back to the participating laboratories. In this manner,each participating laboratory is able to review reports that quantifythe variation in test results experienced among participatinglaboratories.

In the past, the participating laboratories would record a month's worthof test results and mail the results to the central agency at the end ofthe month. This step would take approximately 35 days. The centralagency would then compile the test results received from theparticipating laboratories, compute group statistical summaries of thetest results, and mail reports back to the participating laboratories.This step would take approximately 15-25 days. The disadvantage to thispractice was that the inherent time delay (approximately 50-60 totaldays) limited the usage of the reports to a retrospective look at thequality of the testing services provided by the participatinglaboratories. As a result, even if the reports indicated a malfunctionof a particular laboratory instrument, hundreds or thousands of actualpatient specimens may have already been tested by the instrument.

With the advent of the Internet and other communication networks, manypeer-group quality control programs are now able to process test resultsdynamically on a real-time basis. In practice, a participatinglaboratory transmits test results to the central agency over theInternet on a regular basis. The central agency then receives the testresults, updates the group statistical summaries to include the newlytransmitted test results, and immediately transmits reports back to theparticipating laboratory over the Internet. The advantage to thispractice is that the participating laboratory receives the reports in amuch timelier fashion than the previous mail-in approach.

Traditionally, the internal quality control program of a laboratory hasfunctioned independently of the external quality control program. Thereports received from the central agency (whether in hard-copy form viamail or in electronic form via the Internet) are typically reviewed bysomeone in a managerial role within the laboratory for the purpose ofidentifying extreme variations between the data in the group statisticalsummaries and the internal laboratory statistical data used for internallaboratory testing. If only small variations are detected, nothing isdone to the laboratory test system and the internal quality controlprogram remains unchanged. However, if extreme variations are detected,it may provoke an inquiry as to the origin of the variations to therebytrigger a re-calibration of one or more laboratory instruments. Thus,the external quality control program is only utilized to correct largeerrors in the laboratory test system, while ignoring smaller and moretolerable errors.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to a system and method that enables alaboratory to integrate its internal and external quality controlprograms to thereby control the quality of its laboratory testingservices.

The system of the invention comprises a storage device and a processoroperable to maintain in the storage device a database identifyingvarious sets of relational data. One set of relational data comprises aplurality of laboratory tests and the internal laboratory statisticaldata corresponding to each of the laboratory tests. Another set ofrelational data comprises the plurality of laboratory tests and thegroup statistical summary data corresponding to each of the laboratorytests. Yet another set of relational data comprises the plurality oflaboratory tests and the control rules corresponding to each of thelaboratory tests. The processor is also operable to calculate a controlrange for a specified laboratory test by applying the group statisticalsummary data (and, in some cases, the internal laboratory statisticaldata) to the control rule corresponding to the specified laboratorytest. Preferably, the processor is also operable to receive a testresult from a laboratory instrument, and determine whether the testresult falls within the calculated control range for the specifiedlaboratory test.

Similarly, the computerized method of the invention comprisesmaintaining a database identifying a plurality of laboratory tests andthe corresponding internal laboratory statistical data, groupstatistical summary data and control rules. The method also comprisescalculating a control range for a specified laboratory test by applyingthe group statistical summary data (and, in some cases, the internallaboratory statistical data) to the control rule corresponding to thespecified laboratory test. Preferably, the method also comprisesreceiving a test result from a laboratory instrument, and determiningwhether the test result falls within the calculated control range forthe specified laboratory test.

The present invention will be better understood from the followingdetailed description of the invention, read in connection with thedrawings as hereinafter described.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a system for integrating the internal andexternal quality control programs of a laboratory, in accordance withthe present invention.

FIG. 2 is a block diagram of a first exemplary embodiment of one of thelaboratories of FIG. 1.

FIG. 3 is a block diagram of a second exemplary embodiment of one of thelaboratories of FIG. 1.

FIG. 4 is a block diagram of a third exemplary embodiment of one of thelaboratories of FIG. 1.

FIG. 5 is a block diagram of an exemplary embodiment of the centralagency of FIG. 1.

FIGS. 6A and 6B are flow charts of a method for integrating the internaland external quality control programs of a laboratory, in accordancewith the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENT

The present invention is directed to a system and method that enables alaboratory to integrate its internal and external quality controlprograms to thereby control the quality of its laboratory testingservices. The invention will be described hereinbelow with reference tovarious technical terms, including “processor,” “storage device” and“database.” It should be understood that as used herein (including inthe claims), the term “processor” means either a single processor thatperforms the described processes or a plurality of processors thatcollectively perform the described processes; the term “storage device”means either a single storage device that stores the describeddatabase(s) or a plurality of storage devices that collectively storethe described database(s); and the term “database” means either a singledatabase that identifies the described sets of data or a plurality ofdatabases that collectively identify the described sets of data. Thus,the system and method may be implemented with any number ofprocessor(s), storage device(s) and database(s) without departing fromthe scope of the invention.

Referring to FIG. 1, a system in accordance with the present inventionis designated generally as reference numeral 10. System 10 includes aplurality of participating laboratories 12 a-12 h in communication witha central agency 14 over a plurality of communication links 16 a-16 h.Although eight laboratories have been shown in FIG. 1 (as would becustomary for applications involving hospital and referencelaboratories), it should be understood that system 10 may includehundreds or even thousands of laboratories. As will be described ingreater detail hereinbelow, each of laboratories 12 a-12 h is able tointegrate its internal and external quality control programs byutilizing the group statistical summary data generated by central agency14 in connection with the computation of control ranges for its internallaboratory testing.

Communication links 16 a-16 h may comprise any type of communicationnetwork that is capable of transporting data between laboratories 12a-12 h and central agency 14, such as the Internet. Of course, othertypes of communication networks could also be used, such as any typeand/or combination of local area networks, wide area networks, X.25, andATM. Alternatively, communication links 16 a-16 h may comprise any typeof dedicated line between laboratories 12 a-12 h and central agency 14.

As will now be described with reference to FIGS. 2, 3 and 4,participating laboratories 12 a-12 h may have the same systemconfiguration, different system configurations, or a combination of thetwo (i.e., some laboratories may have the same system configuration andothers may have different system configurations). To show the variousways in which laboratories 12 a-12 h could be implemented, threeexemplary embodiments of system configurations for laboratories 12 a-12h will be described hereinbelow with reference to laboratories 12 a, 12b and 12 c. One skilled in the art will understand, however, that othersystem configurations could also be implemented in accordance with thepresent invention.

Referring now to FIG. 2, a first exemplary embodiment of a systemconfiguration for participating laboratories 12 a-12 h is shown withreference to laboratory 12 a. Laboratory 12 a includes one or morelaboratory instruments 20 connected to a laboratory information system(LIS) 22, which is in turn connected to one or more workstations 24 usedby laboratory workers. While laboratory instruments 20, LIS 22 andworkstations 24 are shown as being co-located together within the samelaboratory, it should be understood that one or more of these systemelements could be located at a remote location (with suitableconnections to the other system elements).

As is known in the art, laboratory instruments 20 may be utilized toperform a variety of different laboratory tests on quality controlspecimens prior to testing actual patient specimens. Laboratoryinstruments 20 may include identical instruments from the samemanufacturer, different instruments from the same manufacturer, ordifferent instruments from a variety of manufacturers. Examples of suchlaboratory instruments include the Olympus AU2700, the Abbott CELL-DYN1700, the Vitros 950, the DPC Immulite 2000, the Bayer Rapidpoint 400,and the Dade Behring PFA 100. Of course, other types of laboratoryinstruments could also be used. Although three laboratory instruments 20have been shown in FIG. 2 for ease of illustration, it should beunderstood that laboratory 12 a may include any number of laboratoryinstruments that are required for the provision of laboratory testingservices. Typically, each of laboratory instruments 20 is connected toLIS 22 via an RS-232 serial connection, although other types ofconnections could also be used.

LIS 22 comprises a computing system that includes a processor 26 and astorage device 28. Examples of well-known computing systems that aresuitable for use with the present invention include server computers,multiprocessor computers and mainframe computers, although othercomputing systems could also be used. Processor 26 is operable toexecute computer-readable instructions stored on a computer-readablemedium to thereby perform the various processes of the presentinvention, as will be described in greater detail hereinbelow. Thecomputer-readable instructions may be coded using the Delphi programminglanguage, although other programming languages could also be used, suchas C, C++, Visual Basic, Java, Smalltalk, Eiffle, PERL and FORTRAN. Thecomputer-readable medium may include any type of computer memory, suchas floppy disks, conventional hard disks, CD-ROMS, Flash ROMS,nonvolatile ROM and RAM.

Workstations 24 each comprise a computing system, such as a personalcomputer or a character terminal, which may be used by a laboratoryworker to initiate certain processes of the invention (e.g., theperformance of laboratory tests on laboratory instruments 20 and/or thesynchronization of data between laboratory 12 a and central agency 14).Although two workstations 24 have been shown in FIG. 2 for ease ofillustration, it should be understood that laboratory 12 a may includeany number of workstations that are required for the provision oflaboratory testing services.

Workstations 24 and LIS 22 preferably operate in a client-serverenvironment, wherein each of workstations 24 operates as the “client”and LIS 22 operates as the “server.” Workstations 24 communicate withLIS 22 via a communication network 30, such as an Ethernet network, atoken ring network, or any other type of local area network or wide areanetwork. Of course, other types of communication networks could also beused.

Referring still to FIG. 2, processor 26 of LIS 22 is operable tomaintain in storage device 28 a database 32 that identifies various setsof relational data, including laboratory tests/test results, laboratorytests/internal laboratory statistical data, laboratory tests/groupstatistical summary data, and laboratory tests/control rules. Each setof relational data is preferably maintained in a separate table withindatabase 32, although other database configurations could also be used.Of course, it should be understood that LIS 22 may include anyrelational database software that is suitable for maintaining thevarious sets of relational data in storage device 28.

A first set of relational data 34 maintained within database 32comprises a plurality of laboratory tests 34 a and the test results 34 bcorresponding to each of the laboratory tests 34 a. The test results 34b for each of the laboratory tests 34 a consist of a collection of testresults that have been obtained from laboratory instruments 20 duringthe internal testing of quality control specimens within laboratory 12a. The first set of relational data will hereinafter be referred to asthe “test results table 34.”

A second set of relational data 36 maintained within database 32comprises the plurality of laboratory tests 36 a and the internallaboratory statistical data 36 b corresponding to each of the laboratorytests 36 a. The internal laboratory statistical data 36 b consists ofthe statistical data (e.g., mean, median, standard deviation,coefficient of variation, standard deviation index, coefficient ofvariation index) derived from the test results 34 b stored within testresults table 34. As such, the internal laboratory statistical data 36 ais based solely on the test results originating from laboratory 12 a.The second set of relational data will hereinafter referred to as the“internal statistics table 36.”

A third set of relational data 38 maintained within database 32comprises the plurality of laboratory tests 38 a and the groupstatistical summary data 38 b corresponding to each of the laboratorytests 38 a. As will be described in greater detail hereinbelow, thegroup statistical summary data 38 b consists of the statistical data(e.g., mean, median, standard deviation, coefficient of variation,standard deviation index, coefficient of variation index) generated bycentral agency 14 for each of the laboratory tests. As such, the groupstatistical summary data 38 b is based on the test results collectedfrom all of the participating laboratories of system 10. The third setof relational data will hereinafter be referred to as the “groupstatistics table 38.”

A fourth set of relational data 40 maintained within database 32comprises the plurality of laboratory tests 40 a and the control rules40 b corresponding to each of the laboratory tests 40 a. Each of thecontrol rules 40 b consists of a formula that yields a lower limit valueand an upper limit value, which together define a range of acceptablevalues (also known as a control range) for each of the laboratory tests.When performing a specified test on a quality control specimen, the testsystem is deemed to be in control when the test result falls within thecontrol range and out of control when the control range is exceeded. Thefourth set of relational data will hereinafter be referred to as the“control rules table 40.”

In accordance with the present invention, the control rules 40 b storedwithin control rules table 40 may be expressed in a variety of differentways. Some of the control rules may be expressed solely as a function ofthe group statistical summary data (e.g., group mean, group median,group standard deviation, group coefficient of variation, group standarddeviation index, group coefficient of variation index) generated bycentral agency 14. For example, for some laboratory tests, the controlrule may be expressed as a target plus or minus an absoluteconcentration (e.g., group mean±1 mg/dL). For other laboratory tests,the control rule may be expressed as a target plus or minus a percentage(e.g., group median±10%). For yet other laboratory tests, the controlrule may be expressed as a target plus or minus the distribution of asurvey group (e.g., group mean±3 group standard deviations). Thus, itcan be seen that regardless of the type of control rule, the calculatedcontrol range is based solely on the group statistical summary data.

Other control rules may be expressed as a function of both the groupstatistical summary data (e.g., group mean, group median, group standarddeviation, group coefficient of variation, group standard deviationindex, group coefficient of variation index) generated by central agency14 and the internal laboratory statistical data (e.g., internal mean,internal median, internal standard deviation, internal coefficient ofvariation, internal standard deviation index, internal coefficient ofvariation index) for laboratory 12 a. For example, for some laboratorytests, the control rule may be expressed as a target plus or minus thedistribution of a survey group (e.g., group mean±2 internal standarddeviations). For other laboratory tests, the control rule may beexpressed as a combination of two different control rules that must bothbe met for the test system to be deemed in control (e.g., internalmean±3 internal standard deviations, and, group mean±1.5 group standarddeviations). For yet other laboratory tests, the control rule may beexpressed relative to the standard deviation index (e.g., ((internalmean−group mean)/group standard deviation)>2) or the coefficient ofvariation index (e.g., (internal coefficient of variation/groupcoefficient of variation)>1.5). Thus, it can be seen that in eithercase, the calculated control range is based in part on the groupstatistical summary data and in part on the internal laboratorystatistical data.

While various types of control rules have been described hereinabove, itshould be understood to one skilled in the art that other types ofcontrol rules that may be expressed as a function of the groupstatistical summary data generated by central agency 14 and/or theinternal laboratory statistical data for laboratory 12 a could also beused.

Referring still to FIG. 2, processor 26 of LIS 22 is also operable toinitiate the performance of various laboratory tests on laboratoryinstruments 20, preferably in response to commands entered by laboratoryworkers via workstations 24. Prior to performing a specified laboratorytest on actual patient specimens, it is common practice to test at leastone quality control specimen to verify that the test result falls withinthe control range for the specified laboratory test. To do so, thequality control specimen is tested on one of laboratory instruments 20(i.e., the laboratory instrument to be used for testing the actualpatient specimens), and the test result generated for that qualitycontrol specimen is transmitted from the laboratory instrument toprocessor 26. It should be understood that this process is repeated foreach of the various quality control specimens that are tested onlaboratory instruments 20.

Upon receipt of the new test results from laboratory instruments 20,processor 26 is operable to transfer the new test results to testresults table 34 for storage in relation to the appropriate laboratorytests. Processor 26 is also operable to re-compute the internallaboratory statistical data for the laboratory tests from the collectionof test results stored within test results table 34 (which now includesthe new test results). Processor 26 is then operable to transfer theupdated internal laboratory statistical data to internal statisticstable 36 for storage in relation to the appropriate laboratory tests.

Processor 26 is further operable to evaluate the new test resultsreceived from laboratory instruments 20 to determine whether laboratoryinstruments 20 are “in control” or “out of control.” To do so, processor26 is operable to calculate the control ranges for the laboratory testsrun on laboratory instruments 20. For example, for those laboratorytests having a control rule that is expressed solely as a function ofthe group statistical summary data, processor 26 is operable tocalculate the control range by applying the group statistical summarydata stored within group statistics table 38 to the control rule storedwithin control rules table 40. Alternatively, for those laboratory testshaving a control rule that is expressed as a function of both the groupstatistical summary data and the internal laboratory statistical data,processor 26 is operable to calculate the control range by applying thegroup statistical summary data stored within group statistics table 38and the internal laboratory statistical data stored within internalstatistics table 36 to the control rule stored within control rulestable 40. Processor 26 is then operable to compare the new test resultsto the calculated control ranges to determine whether the new testresults fall within the calculated control ranges (whereby laboratoryinstruments 20 are deemed to be “in control”) or whether one or more ofthe new test results exceed the control ranges (whereby one or morelaboratory instruments 20 are deemed to be “out of control”).Preferably, processor 26 is operable to display the new test results,calculated control ranges and control status on workstations 24 so thata laboratory worker may manually review the data to determine whether are-calibration of one or more laboratory instruments 20 is required.

Referring still to FIG. 2, processor 26 of LIS 22 is also operable totransmit the new test results received from laboratory instruments 20over communication link 16 a to central agency 14. Preferably, the newtest results are transmitted to central agency 14 in response to asynchronization command entered by a laboratory worker via one ofworkstations 24. Alternatively, the new test results may be transmittedto central agency 14 at a specified date and time (e.g., every 8 hoursof operation), or, the new test results may be transmitted to centralagency 14 automatically as they become available. As will be describedin greater detail with reference to FIG. 5, central agency 14 thenupdates the group statistical summary data with the new test resultsreceived from laboratory 12 a, and automatically transmits the updatedgroup statistical summary data back over communication link 16 a toprocessor 26.

Upon receipt of the updated statistical summary data from central agency14, processor 26 is operable to evaluate the updated group statisticalsummary data for correspondence with the current group statisticalsummary data stored in group statistics table 38. Preferably, the valuesof the updated group statistical summary data are compared with thevalues of the current group statistical summary data to determinewhether there is a variance of more than a specified percentage (e.g.10%). If there is such a variance, processor 26 is operable to flag theupdated group statistical summary data for display on workstations 24 sothat a laboratory worker may manually review the data for possibleadjustment. If there is not such a variance, processor 26 is thenoperable to transfer the updated group statistical data to groupstatistics table 38 for storage in relation to the appropriatelaboratory tests.

Referring now to FIG. 3, a second exemplary embodiment of a systemconfiguration for participating laboratories 12 a-12 h is shown withreference to laboratory 12 b. Laboratory 12 h includes one or morelaboratory instruments 42 connected to a first laboratory informationsystem (first LIS) 44, which is in turn connected to a second laboratoryinformation system (second LIS) 46. Preferably, first LIS 44 and secondLIS 46 are both connected to one or more workstations 48 via acommunication network 49 for operation in a client-server environment.While laboratory instruments 42, first LIS 44, second LIS 46 andworkstations 48 are shown as being co-located together within the samelaboratory, it should be understood that one or more of these systemelements could be located at a remote location (with suitableconnections to the other system elements).

It can be seen that most of the system elements of laboratory 12 b arethe same as those of laboratory 12 a. For example, laboratoryinstruments 42 are the same as laboratory instruments 20, andworkstations 48 are the same as workstations 24. However, as will now bedescribed, first LIS 44 and second LIS 46 are utilized in place of LIS22 (which, as described hereinabove, is specifically configured toperform all of the various processes of the present invention).

First LIS 44 comprises a conventional computing system that is used toinitiate the performance of various laboratory tests on laboratoryinstruments 42 and receive the test results therefrom. It should beunderstood that because first LIS 44 is a conventional system, it is notcapable of utilizing the group statistical summary data generated bycentral agency 14 in connection with the internal testing of qualitycontrol specimens.

Second LIS 46 comprises a computing system that includes a processor 50and a storage device 52. Examples of well-known computing systems thatmay be used for second LIS 46 include server computers, multiprocessorcomputers and mainframe computers, although other computing systemscould also be used. Processor 50 is operable to executecomputer-readable instructions stored on a computer-readable medium tothereby perform the additional processes of the present invention thatare not performed by first LIS 44. The computer-readable instructionsmay be coded using the Delphi programming language, although otherprogramming languages could also be used, such as C, C++, Visual Basic,Java, Smalltalk, Eiffle, PERL and FORTRAN. The computer-readable mediummay include any type of computer memory, such as floppy disks,conventional hard disks, CD-ROMS, Flash ROMS, nonvolatile ROM and RAM.

In accordance with the present invention, processor 50 of second LIS 46is operable to maintain in storage device 52 a database 54 that includesa test results table 56, an internal statistics table 58, a groupstatistics table 60 and a control rules table 62 (which are the same asthe tables described hereinabove with reference to laboratory 12 a).Processor 50 is also operable to import test results from first LIS 44into second LIS 46 and transfer the imported test results to testresults table 56 for storage in relation to the appropriate laboratorytests. Alternatively, the test results may be imported directly fromlaboratory instruments 42 into second LIS 46, or, manually entered intosecond LIS 46.

Processor 50 is also operable to re-compute the internal laboratorystatistical data for the laboratory tests from the collection of testresults stored within test results table 56, which now includes theimported test results. Processor 50 is then operable to transfer theupdated internal laboratory statistical data to internal statisticstable 58 for storage in relation to the appropriate laboratory tests.

Processor 50 is further operable to evaluate the imported test resultsto determine whether laboratory instruments 42 are “in control” or “outof control.” To do so, processor 50 is operable to calculate the controlranges for the laboratory tests corresponding to the imported testresults. Processor 26 is then operable to compare the imported testresults to the calculated control ranges to determine whether theimported test results fall within the calculated control ranges (wherebylaboratory instruments 42 are deemed to be “in control”) or whether oneor more of the imported test results exceed the control ranges (wherebyone or more of laboratory instruments 42 are deemed to be “out ofcontrol”). Preferably, processor 50 is operable to display the importedtest results, calculated control ranges and control status onworkstations 48 so that a laboratory worker may manually review the datato determine whether a re-calibration of one or more laboratoryinstruments 42 is required.

Referring still to FIG. 3, processor 50 of second LIS 46 is alsooperable to transmit the imported test results over communication link16 b to central agency 14. Preferably, the imported test results aretransmitted to central agency 14 in response to a synchronizationcommand entered by a laboratory worker via one of workstations 48.Alternatively, the imported test results may be transmitted to centralagency 14 at a specified date and time, or, the imported test resultsmay be transmitted to central agency 14 automatically as they becomeavailable. As will be described in greater detail with reference to FIG.5, central agency 14 then updates the group statistical summary datawith the imported test results received from laboratory 12 b, andautomatically transmits the updated group statistical summary data backover communication link 16 b to processor 50.

Upon receipt of the updated statistical summary data from central agency14, processor 50 is operable to evaluate the updated group statisticalsummary data for correspondence with the current group statisticalsummary data stored in group statistics table 60. Preferably, the valuesof the updated group statistical summary data are compared with thevalues of the current group statistical summary data to determinewhether there is a variance of more than a specified percentage. Ifthere is such a variance, processor 50 is operable to flag the updatedgroup statistical summary data for display on workstations 48 so that alaboratory worker may manually review the data for possible adjustment.If there is not such a variance, processor 50 is then operable totransfer the updated group statistical data to group statistics table 60for storage in relation to the appropriate laboratory tests.

Referring now to FIG. 4, a third exemplary embodiment of a systemconfiguration for participating laboratories 12 a-12 h is shown withreference to laboratory 12 c. Laboratory 12 c includes one or morelaboratory instruments 64 connected to a laboratory information system(LIS) 66, which is in turn connected to one or more workstations 68 viaa communication network 67 for operation in a client-server environment.While laboratory instruments 64, LIS 66 and workstations 68 are shown asbeing co-located together within the same laboratory, it should beunderstood that one or more of these system elements could be located ata remote location (with suitable connections to the other systemelements).

It can be seen that many of the system elements of laboratory 12 c arethe same as those of laboratory 12 b. For example, laboratoryinstruments 64 are the same as laboratory instruments 42, workstations68 are the same as workstations 48, and LIS 66 is the same as first LIS44 (i.e., a conventional computing system that is used to initiate theperformance of various laboratory tests on laboratory instruments 64 andreceive the test results therefrom). However, laboratory 12 c does notinclude a system element that corresponds to second LIS 46. Rather, theprocesses performed by second LIS 46 are performed by central agency 14(which will be described in greater detail hereinbelow with reference toFIG. 5).

In order for central agency 14 to perform such processes, it mustreceive the test results from laboratory 12 c. Accordingly, in oneembodiment, a Web server 69 is provided that allows a laboratory workerto transfer the test results via e-mail over communication link 16 c tocentral agency 14. Of course, other file exchange protocols could alsobe used, such as HTTP or FTP. Alternatively, in another embodiment, Webserver 69 is provided to allow a laboratory worker to manually enter thetest results via a manual input screen provided on an Internet web siteof central agency 14. However, this alternative is not practical forlaboratories that process large amounts of test results.

Finally, it should be understood that laboratories 12 a, 12 b and 12 chave been described and illustrated hereinabove to show the variety ofsystem configurations that are possible for laboratories 12 a-12 h. Oneskilled in the art will understand that other system configurations forlaboratories 12 a-12 h could also be implemented in accordance with thepresent invention.

As will now be described with reference to FIG. 5, an exemplaryembodiment of a system configuration for central agency 14 is shown.Central agency 14 comprises a central computing system 70 that includesa central processor 72 and a central storage device 74. Examples ofwell-known computing systems that are suitable for use with the presentinvention include server computers, multiprocessor computers andmainframe computers, although other computing systems could also beused.

Central processor 72 is operable to execute computer-readableinstructions stored on a computer-readable medium to thereby perform thevarious processes of the present invention, as will be described ingreater detail hereinbelow. The computer-readable instructions may becoded using the Delphi programming language, although other programminglanguages could also be used, such as C, C++, Visual Basic, Java,Smalltalk, Eiffle, PERL and FORTRAN. The computer-readable medium mayinclude any type of computer memory, such as floppy disks, conventionalhard disks, CD-ROMS, Flash ROMS, nonvolatile ROM and RAM.

Referring still to FIG. 5, central processor 72 is operable to maintainin central storage device 74 a central database 76 that identifiesvarious groups and sets of relational data, as described hereinbelow.Each set of relational data is preferably maintained in a separate tablewithin central database 76, although other database configurations couldalso be used. Of course, it should be understood that central computingsystem 70 may include any relational database software that is suitablefor maintaining the various sets of relational data in central storagedevice 74.

A first group of relational data 78 maintained within central database76 comprises a plurality of individual sets of relational data (one foreach of the participating laboratories of system 10). Each set ofrelational data comprises a plurality of laboratory tests and thecollection of test results corresponding to each of the laboratory testsfor that particular laboratory. This group of relational data willhereinafter be referred to as the “group of test results tables 78.”

Another set of relational data 80 maintained within central database 76comprises the plurality of laboratory tests and the group statisticalsummary data corresponding to each of the laboratory tests (which isderived from testing carried out by specified groups of laboratoryinstruments within the participating laboratories of system 10). Thisset of relational data will hereinafter be referred to as the “groupstatistics table 80.”

Another group of relational data 82 maintained within central database76 comprises a plurality of individual sets of relational data (one foreach of the participating laboratories of system 10 that have the systemconfiguration of laboratory 12 c). Each set of relational data comprisesthe plurality of laboratory tests and the internal laboratorystatistical data corresponding to each of the laboratory tests for thatparticular laboratory. This group of relational data will hereinafterreferred to as the “group of internal statistics tables 82.”

Yet another group of relational data 84 maintained within centraldatabase 76 comprises a plurality of individual sets of relational data(one for each of the participating laboratories of system 10 that havethe system configuration of laboratory 12 c). Each set of relationaldata comprises the plurality of laboratory tests and the control rulescorresponding to each of the laboratory tests for that particularlaboratory. This group of relational data will hereinafter be referredto as the “group of control rules tables 84.”

Referring still to FIG. 5, central processor 72 is also operable toperiodically receive tests results from the various participatinglaboratories of system 10. For a participating laboratory that has thesystem configuration of laboratory 12 a (see FIG. 2) or laboratory 12 b(see FIG. 3), the test results are transmitted from the participatinglaboratory over a communication link for receipt by central processor72. Upon receipt of the test results, central processor 72 is operableto transfer the test results to the appropriate table within the groupof test results tables 78 (i.e., the table assigned to that particularlaboratory) for storage in relation to the appropriate laboratory tests.Central processor 26 is also operable to re-compute the groupstatistical summary data for the laboratory tests from the collection oftest results stored within the group of test results tables 78, whichnow includes the new test results. Central processor 72 is then operableto transfer the updated group statistical summary data to groupstatistics table 80 for storage in relation to the appropriatelaboratory tests. In addition, central processor 72 is operable totransmit the updated group statistical summary data back over thecommunication link to the participating laboratory.

For a participating laboratory that has the system configuration oflaboratory 12 c (see FIG. 4), the test results are either sent viae-mail over a communication link for receipt by central processor 72 orare manually entered via a manual input screen provided on the Internetweb site of central agency 14 for receipt by central processor 72.Regardless of the manner in which the test results are received, centralprocessor 72 is operable to transfer the test results to the appropriatetable within the group of test results tables 78 (i.e., the tableassigned to that particular laboratory) for storage in relation to theappropriate laboratory tests.

Central processor 72 is also operable to re-compute the internallaboratory statistical data for the laboratory tests from the collectionof test results stored within the appropriate table of the group of testresults tables 78 (i.e., the table assigned to that particularlaboratory), which now includes the new test results. Central processor72 is then operable to transfer the updated internal laboratorystatistical data to the appropriate table of the group of internalstatistics tables 82 (i.e., the table assigned to that particularlaboratory) for storage in relation to the appropriate laboratory tests.

In addition, central processor 72 is operable to re-compute the groupstatistical summary data for the laboratory tests from the collection oftest results stored within the group of test results tables 78, whichnow includes the new test results. Central processor 72 is then operableto transfer the updated group statistical summary data to groupstatistics table 80 for storage in relation to the appropriatelaboratory tests.

Central processor 72 is further operable to evaluate the new testresults to determine whether the laboratory instruments of theparticipating laboratory are “in control” or “out of control.” To do so,central processor 72 is operable to calculate the control ranges for thelaboratory tests corresponding to the new test results. Centralprocessor 72 is then operable to compare the new test results with thecalculated control ranges to determine whether the new test results fallwithin the calculated control ranges (whereby the laboratory instrumentsare deemed to be “in control”) or whether one or more of the new testresults exceed the control ranges (whereby one or more of the laboratoryinstruments are deemed to be “out of control”).

Finally, for a participating laboratory that sends its test results tocentral agency 14 via e-mail, central processor 72 is preferablyoperable to send an e-mail back to the laboratory summarizing the newtest results, calculated control ranges and control status so that alaboratory worker may review the data to determine whether are-calibration of one or more of the laboratory instruments is required.Alternatively, for a participating laboratory that manually enters itstest results on the Internet web site of central agency 14, centralprocessor 72 is preferably operable to post the new test results,calculated control ranges and control status to the Internet web site sothat a laboratory worker may access the Internet web site (preferablyvia appropriate authentication procedures, such as a user ID andpassword) and review the data to determine whether a re-calibration ofone or more of the laboratory instruments is required.

Turning now to FIGS. 6A and 6B, a flow diagram of a computerized methodin accordance with the present invention is provided with reference toblocks 100-124. At block 100, a database is maintained that identifiesvarious sets of relational data, including laboratory tests/testresults, laboratory tests/internal laboratory statistical data,laboratory tests/group statistical summary data, and laboratorytests/control rules. Then, at block 102, the set of relational datacontaining the laboratory tests/group statistical summary data isinitialized to contain the updated group statistical data received froma central agency.

At block 104, various laboratory tests are performed on various qualitycontrol specimens using one or more laboratory instruments. Then, atblock 106, the new test results generated by the laboratory instrumentsare transferred to the set of relational data containing the laboratorytests/test results for storage in relation to the appropriate laboratorytests.

Next, at block 108, the internal laboratory statistical data isre-computed for each of the laboratory tests using the test resultsstored within the set of relational data containing the laboratorytests/test results (which now includes the new test results). Then, atblock 110, the updated internal laboratory statistical data istransferred to the set of relational data containing the laboratorytests/internal laboratory statistical data for storage in relation tothe appropriate laboratory tests.

At block 112, the new test results are evaluated to determine whetherthe laboratory instruments are “in control” or “out of control.” To doso, the control ranges for the laboratory tests are calculated andcompared with the new test results. If the new test results fall withinthe calculated control ranges, then the laboratory instruments aredeemed to be “in control” and the method proceeds directly to block 114.However, if one or more of the new test results exceeds the calculatedcontrol ranges, then one or more of the laboratory instruments aredeemed to be “out of control.” In such a case, the new test results,calculated control ranges and control status are flagged for manualreview by a laboratory worker to determine whether re-calibration of oneor more of the laboratory instruments is required.

At block 114, the new test results are transmitted to the centralagency. The new test results may be transmitted to the central agency inresponse to a synchronization command entered by a laboratory worker, ata specified date and time, automatically as new test results becomeavailable, via e-mail, or by manual entry. The central agency 14 thenupdates the group statistical summary data with the new test results.Then, at block 116, the updated group statistical summary data isreceived from the central agency.

At block 118, the updated group statistical summary data is evaluatedfor correspondence with the current group statistical summary datastored in the set of relational data containing the laboratorytests/group statistical summary data. Specifically, the values of theupdated group statistical summary data are compared with the values ofthe current group statistical summary data to determine the variancetherebetween. At block 120, it is determined whether the variance isacceptable. If the variance is not acceptable, at block 122 the updatedgroup statistical summary data is flagged for manual review by alaboratory worker for possible adjustment. On the other hand, if thevariance is acceptable, at block 124 the updated group statisticalsummary data is transferred to the set of relational data containing thelaboratory tests/group statistical summary data for storage in relationto the appropriate laboratory tests. Finally, the method returns to step104 to repeat the processes of blocks 106-124 for another group ofvarious laboratory tests performed on various quality control specimensusing one or more laboratory instruments.

It should be apparent to one skilled in the art that the system andmethod of the present invention described and illustrated hereinaboveprovide several advantages over traditional practices that do notintegrate the internal and external quality control programs of alaboratory. For example, over time, the “tweaking” of small adjustmentsinto the group statistical summary data generated by a central agencywill reduce the variation in test results experienced amongparticipating laboratories of an external quality control program.

Also, because participating laboratories are continually updating thegroup statistical summary data used to calculate the control ranges forinternal laboratory testing, certain test results may be accepted thatwould otherwise be considered erroneous under a traditional analysis(which does not utilize the group statistical summary data). Conversely,certain test results may be considered erroneous that would otherwise beaccepted under a traditional analysis.

In addition, because a majority of the federally mandated laboratoryperformance standards (e.g., outlined in CLIA Regulations 493 and909-959) are specified as a function of the group statistical summarydata, the use of the group statistical summary data to calculate thecontrol ranges for internal laboratory testing allows laboratories tobase their internal quality control practices on the same principlesused by federal regulatory agencies to evaluate laboratory quality.

While the present invention has been described and illustratedhereinabove with reference to several exemplary embodiments, it shouldbe understood that various modifications could be made to theseembodiments without departing from the scope of the invention.Therefore, the invention is not to be limited to the specific systemsand methods described and illustrated hereinabove, except insofar assuch limitations are included in the following claims.

1. A system for integrating the internal and external quality controlprograms of a laboratory utilizing control rules for specifiedlaboratory tests, comprising: at least one storage device located at alaboratory; at least one processor located at the laboratory that isoperable to: maintain in the storage device at least one databaseidentifying a plurality of laboratory tests and corresponding groupstatistical summary data, the database also identifying the plurality oflaboratory tests and corresponding control rules expressed as a functionof the group statistical summary data; calculate a control range for aspecified one of the laboratory tests by applying the group statisticalsummary data for the specified laboratory test to the control rule forthe specified laboratory test whereby the calculated control rangedefines an acceptable range of test result values for the specifiedlaboratory test; receive a test result from a laboratory instrument atthe laboratory for the specified one of the laboratory tests; determinewhether the test result falls within the calculated control range forthe specified laboratory test; receive updated group statistical summarydata from a central agency and determine the variance between theupdated group statistical summary data and the group statistical summarydata; and display the updated group statistical summary data for userreview if the variance between the updated group statistical summarydata and the group statistical summary data exceeds a specifiedpercentage.
 2. The system of claim 1, wherein the processor is furtheroperable to display the test result and calculated control range so thata user at the laboratory can review the test result and calculatedcontrol range to determine whether re-calibration of the laboratoryinstrument is required.
 3. The system of claim 1, wherein the groupstatistical summary data is selected from the following group: a mean, amedian, a standard deviation, a coefficient of variation, a standarddeviation index, a coefficient of variation index, and combinationsthereof.
 4. The system of claim 1, wherein the database also identifiesthe plurality of laboratory tests and corresponding internal laboratorystatistical data, and wherein the processor is operable to calculate thecontrol range for the specified one of the laboratory tests by applyingboth the group statistical summary data for the specified laboratorytest and the internal laboratory statistical data for the specifiedlaboratory test to the control rule for the specified laboratory test.5. The system of claim 1, wherein the processor is further operable toreceive updated group statistical summary data from a central agency andtransfer the updated group statistical summary data to the databasewhereby the updated group statistical summary data becomes the groupstatistical summary data.
 6. The system of claim 5, wherein the updatedgroup statistical summary data received from the central agency isderived from testing carried out by a specified group of laboratoryinstruments.
 7. The system of claim 5, wherein the processor receivesthe updated group statistical summary data from the central agency overthe Internet.
 8. The system of claim 5, wherein the processor isoperable to transfer the updated group statistical summary data receivedfrom the central agency to the database prior to calculating the controlrange for the specified one of the laboratory tests.
 9. The system ofclaim 5, wherein the processor receives the updated group statisticalsummary data from the central agency at a specified date and time. 10.The system of claim 1, wherein the processor is further operable toreceive updated group statistical summary data from a central agency inresponse to a synchronization command.
 11. The system of claim 1,wherein the processor is further operable to transmit the test result toa central agency.
 12. The system of claim 1, further comprising: atleast one central storage device; at least one central processoroperable to: maintain in the central storage device at least one centraldatabase identifying the plurality of laboratory tests and correspondingupdated group statistical summary data; and transmit the updated groupstatistical summary data to the processor.
 13. The system of claim 12,wherein the central storage device and the central processor are locatedat a central agency.
 14. The system of claim 12, wherein the centralprocessor is further operable to receive a plurality of test resultsfrom a plurality of laboratory instruments for incorporation into theupdated group statistical summary data.
 15. A computerized method forintegrating the internal and external quality control programs of alaboratory utilizing control rules for specified laboratory tests,comprising: maintaining at least one database at a laboratoryidentifying a plurality of laboratory tests and corresponding groupstatistical summary data, the database also identifying the plurality oflaboratory tests and corresponding control rules expressed as a functionof the group statistical summary data; calculating a control range atthe laboratory for a specified one of the laboratory tests by applyingthe group statistical summary data for the specified laboratory test tothe control rule for the specified laboratory test whereby thecalculated control range defines an acceptable range of test resultvalues for the specified laboratory test; receiving a test result from alaboratory instrument at the laboratory for the specified one of thelaboratory tests; determining at the laboratory whether the test resultfalls within the calculated control range for the specified laboratorytest; receiving updated group statistical summary data from a centralagency, and determining the variance between the updated groupstatistical summary data and the group statistical summary data; anddisplaying the updated group statistical summary data for user review ifthe variance between the updated group statistical summary data and thegroup statistical summary data exceeds a specified percentage.
 16. Thecomputerized method of claim 15, wherein the group statistical summarydata is selected from the following group: a mean, a median, a standarddeviation, a coefficient of variation, a standard deviation index, acoefficient of variation index, and combinations thereof.
 17. Thecomputerized method of claim 15, wherein the database also identifiesthe plurality of laboratory tests and corresponding internal laboratorystatistical data, and wherein the control range for the specified one ofthe laboratory tests is calculated by applying both the groupstatistical summary data for the specified laboratory test and theinternal laboratory statistical data for the specified laboratory testto the control rule for the specified laboratory test.
 18. Thecomputerized method of claim 15, further comprising receiving updatedgroup statistical summary data from a central agency and transferringthe updated group statistical summary data to the database whereby theupdated group statistical summary data becomes the group statisticalsummary data.
 19. The computerized method of claim 18, wherein theupdated group statistical summary data received from the central agencyis derived from testing carried out by a specified group of laboratoryinstruments.
 20. The computerized method of claim 18, wherein theupdated group statistical summary data received from the central agencyis transferred to the database prior to calculating the control rangefor the specified one of the laboratory tests.
 21. The computerizedmethod of claim 18, wherein the updated group statistical summary datais received from the central agency at a specified date and time. 22.The computerized method of claim 15, further comprising displaying thetest result and calculated control range so that a user at thelaboratory can review the test result and calculated control range todetermine whether re-calibration of the laboratory instrument isrequired.
 23. The computerized method of claim 15, further comprisingtransmitting the test result to a central agency.
 24. The computerizedmethod of claim 15, further comprising receiving updated groupstatistical summary data from a central agency in response to asynchronization command.
 25. A computer-readable medium havingcomputer-executable instructions for performing a method of integratingthe internal and external quality control programs of a laboratoryutilizing control rules for specified laboratory tests, the methodcomprising: maintaining at least one database at a laboratoryidentifying a plurality of laboratory tests and corresponding groupstatistical summary data, said database further identifying theplurality of laboratory tests and corresponding control rules expressedas a function of the group statistical summary data; calculating acontrol range at the laboratory for a specified one of the laboratorytests by applying the group statistical summary data for the specifiedlaboratory test to the corresponding control rule whereby the calculatedcontrol range defines an acceptable range of test result values for thespecified laboratory test; receiving a test result from a laboratoryinstrument at the laboratory for the specified one of the laboratorytests; determining at the laboratory whether the test result fallswithin the calculated control range for the specified laboratory test;receiving updated group statistical summary data from a central agency,and determining the variance between the updated group statisticalsummary data and the group statistical summary data; and displaying theupdated group statistical summary data for user review if the variancebetween the updated group statistical summary data and the groupstatistical summary data exceeds a specified percentage.
 26. Thecomputer-readable medium of claim 25, wherein the group statisticalsummary data is selected from the following group: a mean, a median, astandard deviation, a coefficient of variation, a standard deviationindex, a coefficient of deviation index, and combinations thereof. 27.The computer-readable medium of claim 25, wherein the database alsoidentifies the plurality of laboratory tests and the correspondinginternal laboratory statistical data, and wherein the control range forthe specified one of the laboratory tests is calculated by applying boththe corresponding group statistical summary data and the correspondinginternal laboratory statistical data to the corresponding control rule.28. The computer-readable medium of claim 25, wherein the method furthercomprises receiving updated group statistical summary data from acentral agency and transferring the updated group statistical summarydata to the database whereby the updated group statistical summary databecomes the group statistical summary data.
 29. The computer-readablemedium of claim 28, wherein the updated group statistical summary datareceived from the central agency is derived from testing carried out bya specified group of laboratory instruments.
 30. The computer-readablemedium of claim 28, wherein the updated group statistical summary datareceived from the central agency is transferred to the database prior tocalculating the control range for the specified one of the laboratorytests.
 31. The computer-readable medium of claim 28, wherein the updatedgroup statistical summary data is received from the central agency at aspecified date and time.
 32. The computer-readable medium of claim 25,wherein the method further comprises displaying the test result andcalculated control range so that a user at the laboratory can review thetest result and calculated control range to determine whetherre-calibration of the laboratory instrument is required.
 33. Thecomputer-readable medium of claim 25, wherein the method furthercomprises transmitting the test result to a central agency.
 34. Thecomputer-readable medium of claim 25, wherein the method furthercomprises receiving updated group statistical summary data from acentral agency in response to a synchronization command.
 35. A systemfor integrating the internal and external quality control programs of alaboratory utilizing control rules for specified laboratory tests,comprising: means for maintaining at least one database at a laboratoryidentifying a plurality of laboratory tests and the corresponding groupstatistical summary data and for identifying the plurality of laboratorytests and corresponding control rules expressed as a function of thegroup statistical summary data; means for calculating a control range atthe laboratory for a specified one of the laboratory tests by applyingthe group statistical summary data corresponding to the specifiedlaboratory test to the corresponding control rule whereby the calculatedcontrol range defines an acceptable range of test result values for thespecified laboratory test; means for receiving a test result from alaboratory instrument at the laboratory for the specified one of thelaboratory tests; means for determining at the laboratory whether thetest result falls within the calculated control range for the specifiedlaboratory test; means for receiving updated group statistical summarydata from a central agency, and determining the variance between theupdated group statistical summary data and the group statistical summarydata; and means for displaying the updated group statistical summarydata for user review if the variance between the updated groupstatistical summary data and the group statistical summary data exceedsa specified percentage.
 36. The system of claim 35, wherein the databasemeans also identifies the plurality of laboratory tests and thecorresponding internal laboratory statistical data, and wherein thecalculating means calculates the control range for the specified one ofthe laboratory tests by applying both the corresponding groupstatistical summary data and the corresponding internal laboratorystatistical data to the corresponding control rule.
 37. The system ofclaim 35, further comprising: means for receiving updated groupstatistical summary data from a central agency; and means fortransferring the updated group statistical summary data to the databasemeans whereby the updated group statistical summary data becomes thegroup statistical summary data.
 38. The system of claim 35, furthercomprising means for displaying the test result and calculated controlrange so that a user at the laboratory can review the test result andcalculated control range to determine whether re-calibration of thelaboratory instrument is required.
 39. The system of claim 35, furthercomprising means for transmitting the test result to a central agency.40. A computer-readable medium having computer-executable instructionsfor performing a method of integrating the internal and external qualitycontrol programs of a laboratory utilizing control rules for specifiedlaboratory tests, the method comprising: maintaining at least onedatabase at a laboratory identifying a plurality of laboratory tests andthe corresponding group statistical summary data and the database alsoidentifying the corresponding control rules; receiving updated groupstatistical summary data from a central agency; determining the variancebetween the updated group statistical summary data and the groupstatistical summary data; displaying the updated group statisticalsummary data for user review if the variance between the updated groupstatistical summary data and the group statistical summary data exceedsa specified percentage; transferring the updated group statisticalsummary data to the database whereby the updated group statisticalsummary data becomes the group statistical summary data; receiving atest result from a laboratory instrument at the laboratory for aspecified one of the laboratory tests; calculating a control range atthe laboratory for the specified laboratory test by applying thecorresponding group statistical summary data to the correspondingcontrol rule; and determining at the laboratory whether the test resultfalls within the calculated control range.
 41. The computer-readablemedium of claim 40, wherein the database also identifies the pluralityof laboratory tests and the corresponding internal laboratorystatistical data, and wherein the control range for the specified one ofthe laboratory tests is calculated by applying both the groupstatistical summary data for the test and the internal laboratorystatistical data for the test to the corresponding control rule.
 42. Thecomputer-readable medium of claim 40, wherein the updated groupstatistical summary data received from the central agency is transferredto the database prior to calculating the control range for the specifiedone of the laboratory tests.
 43. The computer-readable medium of claim40, wherein the updated group statistical summary data is received fromthe central agency at a specified date and time.
 44. Thecomputer-readable medium of claim 40, wherein the method furthercomprises transmitting the test result to the central agency.
 45. Thecomputer-readable medium of claim 40, wherein the method furthercomprises displaying the test result and calculated control range sothat a user at the laboratory can review the data to determine whetherre-calibration of the laboratory instrument is required.